One of our large pharmaceutical clients is actively seeking a Deviation Management Specialist to join the sterile supply incoming materials team located in West Point, PA. They will be responsible for ensuring that deviations are thoroughly investigated, risks are managed, and corrective actions are taken to maintain equipment quality & compliance in the pharmaceutical industry. This person needs to have experience authoring investigations & incidents for pharmaceutical manufacturing equipment. Their main responsibility is coordinating QNs (Quality Notifications), identify point of occurrence, investigate root cause, and evaluate product impact by using DM tools to close incidents and investigations by assigned due date. Examples of incidents could include: incorrect build, leak in the area, not documentation correctly, etc. They will be working directly with the shop floor to roll out these changes. This is a hybrid position, 4 days onsite & 1 day WFH.
* Manage investigations from notification through closure meeting timelines to ensure key compliance and customer due dates are met; escalating any potential delays and develop remediation plans when possible.
* Support and/or execution of process improvement projects and complex manufacturing investigations.
* Completes projects to improve the performance of our processes, including investigation Corrective / Preventative Actions (CAPAs), projects aimed at improving "Right First Time" performance or preventing / reducing deviations. Leads and/or works as a team member on complete manufacturing investigations, process improvement and/or validation projects.
* Examines an issue from diverse perspectives (safety, compliance, automation, equipment, process, and people) in order to best understand and resolve the root cause.
* Provides on the floor assistance of operational and technical issues on the shop floor.
* Designs and conducts experimental protocols as needed using the Technical Operations lab facilities and/or production equipment at full scale.
* Authors and updates technical and manufacturing documents necessary for engineering studies or process demonstrations.
* Completes projects to improve the performance of our processes, including investigation Corrective / Preventative Actions (CAPAs), projects aimed at improving "Right First Time" performance or preventing / reducing deviations.
* Promote team safety, environmental, and compliance objectives.
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* B.S. Degree in Engineering or Sciences.
* Technical Writing & Authoring Investigations experience
* Root Cause Analysis experience
* Minimum two years' experience in GMP pharmaceutical manufacturing technical support of GMP manufacturing operations
* Experience working with manufacturing equipment, such as autoclaves, fit testers, washers, dry heat ovens, sonicators
* Experience in deviation management and/or change control and /or equipment or project support role.
* Highly developed communication, leadership and teamwork skills.
* Ability to manage projects/work to schedule/deadlines.
* Background in biologics, vaccine, or bulk sterile manufacturing facilities
* Deviation Management Investigator including Root Cause Certification.
* SAP
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.